Nivolumab Plus Low-Dose Ipilimumab Shows Durable Responses for PD-L1-Negative, TMB-High NSCLC

Excerpt:

“The combination of nivolumab (Opdivo) and low-dose ipilimumab (Yervoy) reduced the risk of progression or death by 52% compared with standard platinum doublet chemotherapy for patients with metastatic PD-L1–negative, tumor mutation burden (TMB)-high non–small cell lung cancer (NSCLC), according to findings from the phase III CheckMate 227 trial presented at the 2018 ASCO Annual Meeting.

“In the PD-L1–negative (<1% expression), TMB-high (≥10 mutations/megabase) subgroup, regardless of histology, median progression-free survival (PFS) with nivolumab/ipilimumab was 7.7 months compared with 5.3 months for chemotherapy and 6.2 months for nivolumab and chemotherapy. The 1-year PFS rate was 45% with nivolumab/ipilimumab compared with 27% for nivolumab/chemotherapy and just 8% for chemotherapy.”

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To PD-L1 or Not to PD-L1: That Is the Question


These days, it seems that I write mostly about immune checkpoint blockade drugs, or some other new immunotherapy treatment for cancer. This post is no different—it covers PD-L1, a protein that is at the center of clinical decisions for selecting patients who are likely to benefit from treatment with an anti-PD-1 or anti-PD-L1 drug. Continue reading…


Tests for New Cancer Drugs Not Reliable Enough, Doctors Say

“Drugmakers including Bristol-Myers Squibb Co and Merck & Co are testing which patients will most benefit from new cancer treatments based on a protein found in their tumors, but that guide, known as a biomarker, may be too unreliable, researchers and health experts said.

“Bristol’s Opdivo and Merck’s Keytruda are both therapies designed to block a protein known as Programmed Death receptor (PD-1) that tumors use to evade the body’s natural defenses. Competitors Roche Holding, AstraZeneca and Pfizer also have similar drugs in an earlier stage of development. The drugmakers are conducting clinical trials that test patient tumors for a related protein called PD-L1.

“The new drugs are mainly aimed at patients with so-called solid tumors suffering from diseases including lung cancer and liver cancer. Lung cancer, the most common type, claims 1.8 million new cases each year worldwide. Sales of drugs to block PD-1 could reach $33 billion a year by 2022, according to Morningstar.”


AstraZeneca and MedImmune Present Positive Immuno-Oncology Combination Data at ASCO 2015

“AstraZeneca AZN, -0.75% and MedImmune, AstraZeneca’s global biologics research and development arm, today presented encouraging results from their novel combination-focused immuno-oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015.

“Overall, data indicated clinical activity with manageable safety profiles for the anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody MEDI4736, both as monotherapy and in combination with other immuno-oncology and small molecule therapies across different tumor types and tumor biology.

“MEDI4736 and tremelimumab combination shows clinical activity and tolerability in both PD-L1 positive and PD-L1 negative advanced non-small cell lung cancer (NSCLC) patients; dose confirmed for future studies

“Results from the combination study of MEDI4736 and tremelimumab, a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, in the treatment of advanced NSCLC, demonstrated clinical activity in heavily-pretreated patients with a manageable safety profile, establishing appropriate doses to move forward into Phase III combination trials.”


AstraZeneca Drug Combination on Track to Fight Lung Cancer

“A closely watched immune system-boosting drug cocktail from Britain’s AstraZeneca shows promise in advanced lung cancer, despite adverse side effects in a number of patients.

“Researchers said on Wednesday that the combination of the experimental drugs MEDI4736 and tremelimumab had ‘a manageable safety profile with evidence of clinical activity, including in PD-L1 negative disease’.

“The update was provided in a scientific summary, or abstract, released ahead of the annual meeting of the American Society of Clinical Oncology (ASCO) later this month.

“MEDI4736 is an anti-PD-L1 therapy, which works by stopping a tumor’s ability to evade the body’s defenses. Tremelimumab blocks a different molecule, CTLA-4, that also keeps the immune system from attacking cancer.”